Capricor Therapeutics Faces FDA Extension and Securities Class Action
News related to:Capricor Therapeutics, Inc · 2 min read
SAN FRANCISCO, Sept. 16, 2026 /CourierPR/ -- Capricor Therapeutics, Inc., a biotechnology company focused on developing treatments for Duchenne muscular dystrophy (DMD), faces a significant setback as the U.S. Food and Drug Administration (FDA) has extended the review period for its lead investigational cell therapy, deramiocel. The extension, which moves the decision date from August 22, 2026, to November 22, 2026, underscores ongoing regulatory and disclosure scrutiny surrounding the company.
On August 24, 2026, Capricor announced that the FDA had extended the Prescription Drug User Fee Act (PDUFA) target action date for deramiocel, a therapy intended to treat DMD. The extension followed a turbulent Advisory Committee meeting in July 2026, where the FDA classified Capricor’s recent submission as a major amendment. This submission included 24-month open-label extension data from the Phase 3 HOPE-3 study and a request to pivot toward a refined indication focused solely on upper limb function.
The company had previously announced positive topline results from the HOPE-3 study on December 3, 2025.
However, the FDA’s July 27, 2026, briefing documents revealed that Capricor had made unagreed-upon post-hoc modifications to its pre-specified Statistical Analysis Plan (SAP). An Advisory Committee subsequently voted 9-3 against the efficacy of the drug, further exacerbating investor losses.
Hagens Berman Sobol Shapiro LLP, a national plaintiffs’ rights law firm with a premier securities practice group, is now notifying investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) of the upcoming September 28, 2026, lead plaintiff deadline in the ongoing securities class action. The firm encourages investors who suffered substantial losses to submit their claims now.
The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for its lead product candidate, Deramiocel. Specifically, defendants allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan without agreement from the FDA prior to resubmitting its Biologics License Application (BLA).
The class period for the lawsuit is from December 17, 2025, to July 26, 2026. Investors who purchased or acquired Capricor securities during this period and suffered significant financial losses have until September 28, 2026, to ask the court to appoint them as lead plaintiff. To learn more about their legal options, investors can visit the firm’s website at www.hbsslaw.com/capr, call Reed Kathrein at 844-916-0895, or email [email protected].